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The treatment landscape of metastatic non small cell lung cancer (NSCLC) is rapidly evolving. There are new diagnostic and treatment options available in the coming months and years.
New combination treatments will give different solutions to pneumo-oncologists who might be guided by certain patient and tumor characteristics.
The link between patient and tumor characteristics in untreated stage IV non small cell lung cancer (NSCLC) patients and systemic treatment needs further investigation, allowing the identification of possible treatment issues, data gaps and/or areas of improvement.
This is a multicenter, non-interventional, cross-sectional study. Consecutive patients with metastatic stage IV non small cell lung cancer (NSCLC) selected for systemic treatment or best supportive care will be included in the trial at the time the patient signed the informed consent form (ICF). Patients that were selected for systemic treatment, should have received at least their first dose and a maximum of one cycle of the same treatment.
The pneumo-oncologist that treats the patient will fill in the CRF, indicating the systemic treatment option and the link with the variable categories that impacted the choice for a systemic treatment option.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary study group | Stage IV untreated NSCLC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None - Common practice | Other | None - Common practice |
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| Measure | Description | Time Frame |
|---|---|---|
| The Study Outcome is Defined as the Systemic Treatment Choice. | Systemic treatment choices are defined as :
| during visits 1 and 2, up to approximately 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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At least 200 stage IV non-small cell lung cancer (NSCLC)subjects treated in approximately 20 Belgian hospitals starting first-line treatment or best supportive care will be enrolled in line with inclusion and exclusion criteria. Assuming that three stage IV NSCLC subjects can be recruited per month per site, enrollment period has been set to 5 months. Only a maximum of 10% of subjects can be enrolled by one site.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA | Antwerp | Belgium | ||||
| ZNA Middelheim |
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Study Group - Single Arm | Stage IV untreated non-small cell lung cancer (NSCLC) Patient disposition:
Total of 215 patients were enrolled in the study at 21 different sites between 03 June 2019 and 31 October 2019. Of the enrolled patients, 209 qualified for inclusion in the Eligible Population (i.e. had given informed consent and satisfied all inclusion criteria and none of the exclusion criteria) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2019 | Oct 17, 2020 |
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| Antwerp |
| Belgium |
| Imelda Ziekenhuis | Bonheiden | Belgium |
| CHIREC | Brussels | Belgium |
| Cliniques Universitaires Saint-Luc UCL Bruxelles | Brussels | Belgium |
| UZ Brussel | Brussels | Belgium |
| CH de Charleroi | Charleroi | Belgium |
| UZ Gent | Ghent | Belgium |
| CH Jolimont | Haine-Saint-Paul | Belgium |
| Jessa Ziekenhuis | Hasselt | Belgium |
| Az Groeninghe Kortrijk | Kortrijk | Belgium |
| UZ Leuven | Leuven | Belgium |
| CHC Liège | Liège | Belgium |
| CHR Citadelle | Liège | Belgium |
| CHU de Liège | Liège | Belgium |
| CHU UCL Namur, site Godinne | Namur | Belgium |
| Clinique St-Pierre Ottignies | Ottignies | Belgium |
| AZ Delta | Roeselare | Belgium |
| AZ St Nikolaas | Saint-Nicolas | Belgium |
| St Trudo Ziekenhuis | Sint-Truiden | Belgium |
| AZ Turnhout | Turnhout | Belgium |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Study Group | A total of 215 patients were enrolled in the study and 209 qualified for inclusion in the Eligible Population (i.e. had given informed consent and satisfied all inclusion criteria and none of the exclusion criteria). All analyses were performed on the Eligible Population.
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Histology | Histology of non small cell lung cancer patients can be divided in squamous, non-squamous, not otherwise specified. | Count of Participants | Participants |
| |||||||||||||||||
| ECOG | The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. Ranging from 0 (fully active) to 5 (dead). | Count of Participants | Participants |
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| Smoking Status | Smoking status is definde as current, former (former smoker defined as ≥ 1 year), never, or unknown | Count of Participants | Participants |
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| IHC PD-L1 | Clinical trials have shown the association of programmed cell death 1 (PD-L1) expression by immunohistochemistry (IHC) with higher overall response rates to the PD-1/PD-L1 axis blockade suggesting that PD-L1 expression may serve as a predictive marker. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Study Outcome is Defined as the Systemic Treatment Choice. | Systemic treatment choices are defined as :
| Posted | Count of Participants | Participants | during visits 1 and 2, up to approximately 3 weeks |
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Timeframe between Visit 1 and 2 varied between same day (0 days in between) and 3 weeks maximum.
Adverse Event Reporting INVESTIGATOR RESPONSIBILITY: If the investigator becomes aware of any serious adverse event (SAE), including death due to any cause, or non-serious adverse reaction (NSAR) following the use of any Merck product, the event must be reported according to Table 1. The investigator must evaluate each SAE for causality and record causality on the AE form for each event reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Study Group - Single Arm | This is a primary data collection non-interventional study being conducted within routine medical practice. All direction for medication usage is at the discretion of a physician in accordance with usual medical practice. No administration of any therapeutic or prophylactic agent is required in this protocol, and there are no procedures required as part of this protocol. | 4 | 215 | 13 | 215 | 1 | 215 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| pericardial fluid accumulation | Cardiac disorders | Non-systematic Assessment |
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| Worsened general condition | General disorders | Non-systematic Assessment |
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| Brain metastasis (progression) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Inflammatory folliculitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hospitalisation | General disorders | Non-systematic Assessment |
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| Eosinophelia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Hospitalization | Nervous system disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Cutaneous eruption | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Eosinophelia | Blood and lymphatic system disorders | Non-systematic Assessment |
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The experiment is not interventional and cross sectional.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Coulon | MSD Belgium | 0032 485 461 467 | stephanie.coulon@merck.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 4, 2019 | Oct 17, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Non-squamous |
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| Not otherwise specified |
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| ECOG 1 |
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| ECOG 2 |
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| ECOG 3-4 |
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| Unknown |
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| Former (>1 year) |
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| Never |
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| Unknown |
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| Tumor Proportion Score (TPS) 1-49% |
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| Tumor Proportion Score (TPS) >=50% |
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| Unknown |
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| Immunotherapy + chemotherapy |
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| Immunotherapy + bevacizumab + chemotherapy |
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| Best supportive care |
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